Pefloxacin single-dose in the treatment of acute uncomplicated lower urinary tract infections in women: a meta-analysis of seven clinical trials.

The objective of the meta-analysis was to assess the efficacy and safety of a single oral dose of 800 mg pefloxacin in the treatment of acute uncomplicated lower urinary tract infections in women. A total of 1578 women were enrolled in five controlled (four double-blind and one open) and two non-comparative multicentre clinical trials. The comparative treatment regimen in the five controlled trials was trimethoprim-sulfamethoxazole in four studies, and norfloxacin in one study. Trimethoprim-sulfamethoxazole was administered orally 160/800 mg twice daily for 3-7 days, norfloxacin 400 mg b.i.d. for 5 days. Analyses of these studies were performed for the intent-to-treat population and safety population. The 1298 patients (815 patients with pefloxacin, 404 with trimethoprim-sulfamethoxazole, and 79 with norfloxacin) included in the intent-to-treat-analysis were those with clinical signs and symptoms of acute cystitis and significant bacteriuria (>/=10(5) cfu/ml midstream urine) who received a single oral dose of pefloxacin or were treated with the control drug. Success rates of pefloxacin achieved 4 to 6 weeks after the start of treatment ranged from 65.8% to 97.7% for cure or improvement of clinical signs and symptoms and from 53.8% to 90.5% for bacteriological eradication (trimethoprim-sulfamethoxazole 69.1% to 92.5% abd 52.1% to 85.1%, and norfloxacin 74.7% and 58.2%, respectively). The pooled percentage of patients in whom pefloxacin therapy cured or improved clinical symptoms was 82.5% (95% CI: 79.7% to 85.0%). The pooled rate of bacteriological eradication was 76.3% (95% CI: 73.2% to 79.2%). The pooled success rates of trimethoprim-sulfamethoxazole were 82.7% (95% CI: 78.6% to 86.2%) for clinical cure or improvement, and 74.3% (95% CI: 69.7% to 78.5%) for bacteriological eradication. Testing for equivalence between pefloxacin and trimethoprim-sulfamethoxazole in an exploratory sense, the minimal equivalence region with significant results was 4.1% points for clinical cure or improvement (P < 0.05) and 6.5% points for bacteriological eradication (P < 0.05). Adverse events were reported in 235 out of 987 patients treated with pefloxacin. The pooled incidence was 23.8% (incidence in individual studies 13.5% to 47.3%). The pooled incidence of adverse events associated with the use of the comparative drugs was 20.5% (incidence in individual studies 5.9 to 47.7%).